Drugs and dietary supplements: what can we prescribe to patient and when

Oksana D. Nemyatyh , Sergey K. Zyryanov , Anatoliy V. Abricov

For citation:

Abstract

Probiotic drugs are currently widely used in clinical practice. However, the items offered in the today’s Russian pharma market may have a registration status of dietary supplements (BAAs) that is fundamentally different in approaches to development. BAAs are not drugs, their production and selling is not subject to licensing. Experts of pharma market and healthcare system together with the legal professional address difficulties related to BAA prescription in clinical practice. In contrast to drugs, BAAs have no indications for use registered and confirmed by the regulatory authority, while each indication stated in the instructions for medical use of the drug is based on the results of appropriate studies. In this regard, it is extremely important to ensure that patients understand the real BAA effects and clearly state that it is not a drug, since, in case of damage caused to the life and health of the patient, medical institution and the physician shall bear civil liability.
Key words: drugs, BAA, dietary supplements, responsibility, indications, regulation.

References

1. Федеральный закон от 21.11.2011 №323-ФЗ (ред. от 24.07.2023). Об основах охраны здоровья граждан в Российской Федерации (с изм. и доп., вступ. в силу с 01.09.2023).

Federal Law No323-FZ of 21.11.2011 (as amended on 24.07.2023). On the basics of public health protection in the Russian Federation (with amendments and additions, intro. effective from 01.09.2023) (in Russian).

2. Рубрикатор клинических рекомендаций. Минздрав России. URL: https://cr.minzdrav.gov.ru/

Rubricator of clinical recommendations. The Ministry of Health of Russia. URL: https://cr.minzdrav.gov.ru/ (in Russian).

3. Приложение №1 Порядок назначения лекарственных препаратов к приказу Минздрава России от 14 января 2019 г. №4н.

Appendix No1 Procedure for prescribing medicines to the Order of the Ministry of Health of the Russian Federation dated January 14, 2019 No4n (in Russian).

4. Федеральный закон от 12.04.2010 №61-ФЗ. Об обращении лекарственных средств.

Federal Law No61-FZ of 12.04.2010. About the circulation of medicines (in Russian).

5. Клинические рекомендации. Ротавирусный гастроэнтерит у детей. Дата обращения: 03.11.2023. URL: https://cr.minzdrav.gov.ru/recomend/755_1

Clinical recommendations. Rotavirus gastroenteritis in children. Date of application: 03.11.2023. URL: https://cr.minzdrav.gov.ru/recomend/755_1 (in Russian).

6. ГОСТ Р 56034–2014 «Клинические рекомендации (протоколы лечения). Общие положения». Электронный ресурс. Дата обращения: 03.11.2023. URL: http://docs.cntd.ru/document/1200110991

GOST R 56034-2014 "Clinical recommendations (treatment protocols). General provisions". Electronic resource. Accessed: 03.11.2023. URL: http://docs.cntd.ru/document/1200110991 (in Russian).

7. Ковалева М.Ю., Сухоруких О.А. Клинические рекомендации. История создания и развития в Российской Федерации и за рубежом. Ремедиум. Журнал о рынке лекарств и медицинской техники. 2019; (1–2): 6–14.

Kovaleva MY, Sukhorukih OA. Clinical recommendations. History of creation and development in the Russian Federation and abroad. Remedium. Journal about the market of medicines and medical equipment. 2019; (1–2): 6–14 (in Russian).

8. Постановление Правительства РФ от 17 ноября 2021 г. №1968. Об утверждении Правил поэтапного перехода медицинских организаций к оказанию медицинской помощи на основе клинических рекомендаций, разработанных и утвержденных в соответствии с частями 3, 4, 6–9 и 11 статьи 37 Федерального закона «Об основах охраны здоровья граждан в Российской Федерации».

Decree of the Government of the Russian Federation No1968 dated November 17, 2021. On Approval of the Rules for the Gradual Transition of Medical Organizations to Providing Medical Care based on clinical recommendations developed and approved in accordance with Parts 3, 4, 6-9 and 11 of Article 37 of the Federal Law "On the Basics of Public Health Protection in the Russian Federation" (in Russian).

9. Постановление Правительства РФ от 02.07.2020 №973 (ред. от 01.02.2022). Об особенностях организации оказания медицинской помощи при угрозе распространения заболеваний, представляющих опасность для окружающих.

Decree of the Government of the Russian Federation No973 dated 02.07.2020 (ed. dated 01.02.2022). About the peculiarities of the organization of medical care in case of the threat of the spread of diseases that pose a danger to others (in Russian).

10. Приложение №3. Требования к структуре клинических рекомендаций, составу и научной обоснованности включаемой в клинические рекомендации информации к приказу Минздрава России от 28 февраля 2019 г. №103н.

Appendix No3. Requirements for the structure of clinical recommendations, the composition and scientific validity of the information included in clinical recommendations to the Order of the Ministry of Health of the Russian Federation dated February 28, 2019 No. 103n (in Russian).

11. Клинические рекомендации. Нарушения митохондриального

β-окисления жирных кислот. Дата обращения: 03.11.2023. URL: https://cr.minzdrav.gov.ru/schema/694_1

Clinical recommendations. Disorders of mitochondrial β-oxidation of fatty acids. Date of application: 03.11.2023. URL: https://cr.minzdrav. gov.ru/schema/694_1 (in Russian).

For citation:Nemyatyh O.D., Zyryanov S.K., Abricov A.V. Drugs and dietary supplements: what can we prescribe to patient and when. Clinical review for general practice. 2023; 4 (7): 85–93 (In Russ.). DOI: 10.47407/kr2023.4.7.00292

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Clinical review for general practice